ES2554136A2 - Remote monitoring system of multiple vital signs and automatic diagnosis of cardiovascular pathologies in patients, with data transmission by mobile technology and activation of the medical emergency protocol. (Machine-translation by Google Translate, not legally binding) - Google Patents

Abstract

The invention that we present consists of a remote monitoring system of multiple vital signs that performs an automatic diagnosis of the patient and executes a medical attention protocol in case of detecting underlying cardiovascular pathologies. The system comprises a new multifunctional patch that adheres to the patient's body in a comfortable and discreet manner. Automatically, this patch registers multiple vital signs, constantly diagnoses the patient and transmits the data to a mobile phone via bluetooth technology. The mobile phone includes a software application that receives the patch data and immediately transmits it via the internet to one or more remote medical control centers. (Machine-translation by Google Translate, not legally binding)

Description

DESCRIPTION

Remote monitoring system of multiple vital signs and automatic diagnosis of cardiovascular diseases in patients, with data transmission by mobile technology and activation of the medical emergency protocol. 5

The invention at hand consists of a remote monitoring system of multiple vital signs that also performs an automatic diagnosis of the patient and executes a medical care protocol in case of detecting underlying cardiovascular pathologies. It is a system characterized by monitoring and evaluating the health status of the person 24 hours a day and from anywhere in the world, in addition to executing an optimized medical care protocol that treats the patient in situ and in a minimum time . The system we present includes a new multifunctional patch that adheres to the patient's body. This patch is characterized in that it contains a battery of intelligent biometric sensors that measure and record 15 multiple vital signs, a data processor with a self-diagnostic algorithm that detects alterations in the patient's constants and recognizes the associated cardiovascular pathologies and a transmitter / wireless receiver that transmits data with Bluetooth technology. On the other hand, the system has a smart mobile phone characterized by including a software application that receives the data from the patch and transmits it, together with the GPS coordinates of the phone, to a remote medical center via the Internet. If the patch detects signs indicative of a cardiovascular pathology, it immediately sends an emergency alarm to the mobile phone and transmits it to the remote medical center immediately. Finally, the remote medical control center receives patient data through Web services. This center has 25 management software that organizes and stores the information on database servers accessible only by authorized personnel. Likewise, this program continuously monitors the patient's vital signs and, in case of receiving an emergency alarm, immediately informs the medical center staff. If necessary, the medical center starts the emergency protocol to treat the patient as soon as possible. With this new system, it is intended that people susceptible to having a heart attack or other type of cardiovascular insufficiency are monitored 24 hours a day even outside the hospital setting. Through this system, doctors can observe the patient's vital signs in real time and assess their state of health at any time regardless of the place and / or how far away from their job.

Technical sector

The present invention falls within the biotechnology sector referred to the field of preventive medicine, more specifically in relation to early diagnosis and optimization of on-site medical care protocols.

State of the art

 Four. Five

According to the World Health Organization: "coronary heart disease is the most important cause of death worldwide; it continues to increase and has become a true pandemic that does not respect borders." In view of the facts, the medical authorities consider that an effective way to combat the rising mortality rate due to cardiovascular disease, apart from leading a healthy life, is to constantly monitor the health status of those susceptible to suffering from

heart attack or any other cardiovascular insufficiency, even being outside the hospital setting. For this reason, authors from different disciplines have developed systems that include electronic patches that adhere to the patient's chest and monitor their health status, some remotely, while he develops his daily life. However, the systems that have been developed have some important limitations. First, most of these devices only monitor the patient's electrocardiogram. However, to make an accurate assessment of a person's health status, it is important to take into account other vital signs, such as blood pressure or blood oxygen saturation. This is the case of the invention described in the patent No. US20110237922, which consists of an electronic patch 10 with an inverted T-shape that only obtains the electrocardiogram of the patient and transmits the data to a mobile terminal via Bluetooth technology. This model has a total of six electrodes and uses the EASI algorithm to obtain an ECG of twelve leads by calculating averaged readings. The EASI algorithm is sufficient to keep patients monitored when they are out of danger, but in the case of an ischemic event, for example, it is essential to have a twelve lead ECG calculated from the reading of ten electrodes, since it allows to assess the state of health of the person accurately. In the particular case of patches that only monitor the electrocardiogram, there is an added problem that lies in the placement of the electrodes. In fact, the majority of errors when performing an ECG are 20 due to the incorrect placement of any of them. To solve this problem, there have been many attempts to create a patch that integrates the ten electrodes necessary to obtain a twelve-lead ECG with quality for diagnosis. In this sense, the most remarkable invention is that described in patent No. US5938597, which includes the electrodes corresponding to the precordial leads in their corresponding anatomical location and the electrodes of members at the ends of the patch. However, the design proposed by this patent is intended for use in male patients, since proper electrode placement is complicated in women due to their anatomy. Likewise, in US Patent No. 6,847,836 it is mentioned that in order for the use of these electronic patches to be effective, 30 should be manufactured in five different sizes to adapt the position of the electrodes to the patient's chest size. There are also electronic patches that monitor blood pressure and / or blood oxygen saturation, as is the case of the invention described in US Patent No. US20050228299 A. In this other case, the information received by the doctor is still not enough, since if you want to evaluate the health status of the patient with precision, it is necessary to have the electrocardiogram. Apart from all these new generation electronic patches, today, the Holter monitor is still the system most used by doctors for monitoring cardiovascular diseases. It is a small electronic device that works with batteries and that records and stores in a recorder the electrical activity of the heart for at least 24 hours, on an outpatient basis and without the need for hospitalization, which allows the patient to make his life Daily without restrictions.

Once the registration is completed, the device is connected to a computer and the collected data is downloaded. From these data, the doctor can detect arrhythmias and 45 blood pressure disorders that in the consultation would be very difficult to diagnose. Holter is specifically used to diagnose heart rhythm disturbances and rarely to detect coronary heart disease such as heart attack or ischemia. There is also the blood pressure Holter, similar to the ECG Holter with the difference that instead of using cables and electrodes attached to the patient's body, this other device uses a 50-pressure cuff placed on the arm. Every 20 minutes, this cuff is inflated and

Take blood pressure. The values obtained with each reading are stored in a recorder that, upon completion of the registration, is connected to a computer and the information is downloaded. Another determining factor in cardiovascular disease mortality is the time it takes to assist the patient. It is essential to understand that 65% of deaths occur before the patient arrives at the hospital. In this sense, there is a chain of factors that hinder the rapid transfer of the patient to the hospital and, consequently, aggravate the prognosis. The first limitation is the delays due to the fact that the witnesses of the infarction or the patient himself take too long to notify the emergency system, It may even be the case in which the patient is alone and cannot request help for himself. Currently, the average time between 10 the onset of symptoms until consultation with the health system exceeds 95 minutes. In any of these situations, none of the aforementioned systems have the ability to detect an underlying cardiovascular pathology and automatically inform a medical center in case of emergency. "Specifically in these cases there is a time, known as the" time golden "to be able to be transferred 15 to an intensive cardiovascular unit. The average 95 minutes clearly exceed the" golden hour ".

When a heart attack occurs, it is essential to perform a twelve-lead electrocardiogram as soon as possible and complete it with the symptoms referred by the patient to obtain a precise diagnosis. Normally, this first ECG is performed in the emergency department of the destination hospital. Patent No. US2013 / 0035571 A1, describes a system for obtaining the electrocardiogram and reading other vital signs in the ambulance itself while the patient is transported on the way to the hospital. In addition, this system sends the data to the destination hospital, so that the cardiology staff is prepared to intervene the patient upon arrival. Although the system is faster to detect and send the information to a medical center or cardiologist, it depends on the paramedical team reaching the patient to obtain a diagnosis.

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Description of the invention

Remote monitoring system of multiple vital signs and automatic diagnosis of cardiovascular diseases in patients, with data transmission by mobile technology and activation of the medical emergency protocol. 35

The invention that concerns us comprises a system for monitoring and remote diagnosis of cardiovascular pathologies and multiple automatic vital signs of the patient (0101) and executes a medical care protocol in case of detecting underlying cardiovascular pathologies. This system contains an innovative multifunctional patch 40 (0102), a mobile smart phone (0103) and one or more remote medical control center (s) (0104). FIG. 1 shows, in general terms, the operating dynamics of the system at hand. The multifunctional patch (0102) records multiple vital signs, diagnoses the patient (0101) automatically 24 hours a day and transmits the data to the mobile phone (0103) constantly using Bluetooth technology. The mobile phone (0103) includes a software application (FIG. 7 and FIG. 8) that receives the data sent by the patch (0102), determines the geographical position of the mobile phone (0103), sends the information to the Medical Control Center remote (0104) and informs both the patient (0101) and the Remote Medical Control Center (0104) of any malfunction. The Medical Control Center 50 (0104) stores the information it receives from the mobile phone (0103), supervises the

Vital signs of the patient (0101) in real time, executes the action plans corresponding to a technical failure in the system and starts the protocol of medical care in case of an emergency. When the multifunctional patch (0102) detects an alteration in the patient's vital signs (0101) that implies the beginning of an underlying cardiovascular pathology, it sends an alarm indicating to the mobile phone (0103) indicating a medical emergency situation. The software application installed on the mobile phone (0103) transmits this alarm to the remote Medical Control Center (0104) immediately, indicating the most likely pathology suffered by the patient (0101). Since the Remote Medical Control Center (0104) knows the coordinates that determine the exact location of the patient (0101), the medical care protocol (FIG. 11 and FIG. 12) starts up 10 even when the patient (0101 ) is unable to request help for himself. All this happens inadvertently for the patient (0101).

Multifunctional patch

 fifteen

The multifunctional patch (0102) consists of a multifunction electronic device that adheres to the patient's chest (0101). This patch (0102) is characterized in that it comprises a battery of intelligent biometric sensors that measure and record multiple vital signs, a data processor with an innovative self-diagnosis algorithm that recognizes cardiovascular pathologies and a wireless transmitter / receiver 20 that transmits the data to the mobile smart phone (0103) by Bluetooth technology. It is a wireless, lightweight and comfortable device that the patient (0101) can carry with him, comfortably and discreetly, while he records his vital signs and assesses his health status 24 hours a day.

 25

FIG. 2 shows a graphic representation of the electronic implementation of the patch (0102). This patch is characterized by being implemented with a fully decentralized architecture that contains a series of independent functional units. It is a multi-task device that stands out for its high functional performance because the different units work at the same time and deforms independently. The peripheral sensor unit (0201) is characterized in that it contains a Bluetooth technology data transmitter / receiver that picks up the signals of other wireless sensors that the patient could carry with him (0101). In this way, the patch (0102) can keep the record of other vital signs apart from those included by default. The electrocardiography unit (0202) comprises an electrocardiograph fully integrated in the patch (0102). This unit is characterized by capturing the electrical impulses of the heart and obtaining a twelve-lead electrocardiogram with signal quality for diagnosis. The electrical signals that correspond to each branch are conditioned by the unit itself through both analog and digital implementation filters. The electrocardiography unit (0202) 40 contains ten surface electrodes distributed strategically and in permanent contact with the patient's skin (0101). Precordial C1, is located in the fourth right intercostal space on the right edge of the sternum, precordial C2, is located in the fourth left intercostal space on the left edge of the sternum, precordial C3. It is between C2 and C4. precordial C4. it is located in the middle clavicular line at the height of the left nipple 45, precordial C5, it is located in the anterior axillary line, precordial C6, it is located in the middle axillary line, AA is in the right arm, located in the intercostal space immediately above C1. LA is on the left arm, located in the intercostal space immediately above C2. the LL is in the left leg, vertically four intercostal spaces below the C5, RL is in the right leg or 50 neutral, and is located vertically just below the LL in the left intercostal. The unit of

Electrical supply (0203) is characterized by the fact that it contains an electric battery where electrical energy is stored and distributed for all the circuits and electronic components of the patch (0102). The management unit (0204) is characterized by coordinating the overall operation of the patch (0102) and is implemented with a microcontroller. This unit constantly checks the operability of each module, 5 informs the alarm unit (0208) of any incident, receives the data corresponding to the vital signs recorded by the electrocardiography unit (0202), blood pressure (0207), of temperature (0205), body tilt (0206) and peripheral sensor (0201); calculates indirect vital signs from the recorded signals and stores the data in the memory unit (0209). The indirect 10 constants it calculates are: heart rate and respiratory rate. The temperature unit (0205) is characterized in that it contains a thermistor that measures and records the patient's body temperature (0101). It has a contact terminal (0311) placed in the middle axillary area just above the precordial electrode C6 (0506) (FIG 5a-d). The body inclination unit (0206) is characterized in that it contains a three-dimensional accelerometer that constantly calculates the inclination of the patient's body (0101) in the three spatial axes. The blood pressure unit (0207) consists of a reflectance photoplethysmograph, which measures the patient's blood oxygen saturation (0101) and calculates his blood pressure. To do this, it has a photodiode, a red light emitting LED and another infrared light emitting LED, encapsulated in the 20 head (0512) located in the intercostal space immediately above the precordial electrode C3 (0503) (FIG. 5a and FIG. 5c) or vertically just above the LL electrode (0509) (FIG. 5b and FIG. 5d) The alarm unit (0208) is characterized by alerting the patient (0101) through acoustic, light indicators and vibratory on any failure or incident occurred during the operation of the patch (0102). The memory unit (0209) is characterized in that it contains a double-port electronic memory where the register of the different vital signs is temporarily stored. The diagnostic unit (0210) is characterized by containing another micro-controller programmed with a self-diagnostic algorithm, which constantly evaluates the patient's health status (0101) based on the vital signs recorded by the device. In addition to diagnosing, this unit is also characterized by checking the operability of the communications unit (0211), establishing the connection with the mobile phone (0103), informing the management unit (0204) of any incident that has occurred during its operation, to read the data of the memory unit (0209) and to transmit to the telephone (0103) the record of vital signs and the result of the diagnosis. The communications unit (0211) is characterized in that it contains a Bluetooth transmitter / receiver through which the patch (0102) transmits the registration of vital signs and the diagnosis result to the mobile smart phone (0103). The NFC unit (0212) is characterized in that it contains a passive NFC technology label that contains the patch identification code (0102). FIG. 40 3 shows a flow chart describing the general operation of the management unit (0204). When the patch (0102) starts up, the management unit (0204) performs a reading on the status of each of the other units to check its operation. First, check the charge level of the battery that supplies the electric power (process (0301). In case the charge level is below 10% of the total, it is communicated to the alarm unit ( 0208) that the battery charge is in critical condition (process (0302). If the charge level is above 10% of the total charge, the current battery status is communicated to the alarm unit (0208) (process 0303) and the verification of the memory unit (0209) (process 0304) is continued. If this other unit responds with a malfunction, the 50 alarm unit (0208) receives an alert message to indicate to the patient (0101) that

There is a technical fault that prevents storing data in the internal memory (0209) of the patch (0102) (process 0305).

If there are no errors, the operation of the electrocardiography unit (0202) (process 0306) is checked. If there is an error in this unit, which prevents it from functioning normally, the alarm unit (0208) receives an alert to indicate to the patient (0101) that the electrocardiograph does not work properly (process 0305). In addition, this same alert is recorded in the memory unit (0209) and then transferred to the telephone (0103) through the communications unit (0211) (process 0308). If the electrocardiography unit (0202) has no errors, the operation of the blood pressure unit (0207) is checked (process 0307). Again, if this is the case in which this unit presents an error that prevents it from functioning correctly, the alarm unit (0208) receives an alert to indicate to the patient (0101) that the photoplethysmograph does not work normally (process 0305) . In addition, this same alert is recorded in the memory unit (0209) and then transferred to the telephone (0103) through the communications unit (0211) (process 0308). If there are no errors in this unit, the temperature unit check (0205) is continued (process 0309). In the same way, if this unit reports a malfunction, the alarm unit (0208) immediately receives an alert to indicate to the patient (0101) that the thermometer is not working properly (process 20 0305). This same alert is recorded in the memory unit (0209) and then transferred to the telephone (0103) through the communications unit (0211) (process 0308). If there are no errors, the operation of the body tilt unit (0206) (process 0310) is checked. Similarly, if this unit reports a malfunction, the alarm unit (0208) receives an alert to indicate to the patient (0101) that the accelerometer is not operational (process 0305). As in the previous cases, this alert is registered in the memory unit (0209) and then transferred to the telephone (0103) through the communications unit (0211) (process 0308). Finally, the management unit (0204) finishes checking the units, verifying the peripheral sensor unit (0201) (process 0311). If this unit does not have operating errors, the results obtained are registered in the memory unit (0209), and you will be prompted to start the search for other wireless sensors that the patient could carry (0101) (process 0312). In the case of finding an external sensor, the peripheral sensor unit (0201) receives instructions to establish the connection via Bluetooth (process 0313). In the event that this unit 35 has operating errors, does not find external sensors or cannot establish a connection with one, the alarm unit (0208) receives an alert to indicate to the patient (0101) the specific situation of the sensor unit peripheral (0201) (process 0305). In the same way as in all the previous cases, the alert is recorded in the memory unit (0209) and then transmitted to the telephone (0103) 40 through the communications unit (0211) (process 0308). Once the operation of each unit has been checked, the management unit (0204) continues with the execution of the tasks for which it has been programmed. Cyclically, the management unit (0204) checks the battery status (process 0301) and informs the alarm unit (0208) about the charge level (process 0303). Next, 45 checks if the diagnostic unit (0210) is operational (process 0314). If it does not work properly, the alarm unit (0208) receives an alert to inform the patient (0101) of the error (process 0305). In the event that the diagnostic unit (0210) is operational, the electrocardiography unit (0202) is instructed to verify electrodes of the electrocardiograph (process 0315). fifty

If everything is correct, the management unit (0204) proceeds to read data from the different units of measurement (processes 0316, 0317, 0318, 0319 and 0321). If there is an error in the reading of any unit, the alarm unit (0208) receives an alert to inform the patient (0101) of a reading error (process 0305). One time

Once all the data is recorded, the management unit (0204) calculates the heart rate and the patient's breathing rate (0101) from the data obtained by the other units (process 0322). Finally, the information is stored in the memory unit (0209) (process 0323) and the cycle is repeated continuously.

FIG. 4 shows a flow chart representing the general operating dynamics of the diagnostic unit (0210). When starting the patch (0102), a reading is made on the status of the different units with which this unit interacts. First, the diagnostic unit (0210) informs the management unit (0204) that it is not yet operational (process 0401). Next, the communication with the memory unit (0209) is verified (process 0402). If there are no errors, the operability of the communications unit (0211) (process 0403) is checked and, if operating normally, it is ordered to start the search for the mobile phone (0103) (process 0404) and that establish the connection via Bluetooth if it is detected (process 0405). If the communication unit (0211) reports that the connection with the mobile phone (0103) has been established successfully, then the diagnostic unit 20 (0210) indicates to the management unit (0204) that it is operational (process 0406).

At this point, the diagnostic unit (0210) waits to be informed by the management unit (0204) about the availability of data in the memory unit (0209) (process 0407). If new data is available, the reading of the same 25 is carried out (process 0408) and the self-diagnosis algorithm is executed to assess the patient's health status (0101) and store the result in the unit of memory (0209) (process 0409). Once the analysis of the variables is finished, the diagnostic unit (0210) transfers the data stored in the memory unit (0209) to the communications unit (0211) to send the information to the mobile phone (0103) (process 30 0410) . If the communications unit confirms that the mobile phone (0103) has received the information correctly (process 0411), then the diagnostic unit (0210) again waits for the availability of new data in the memory unit (0209) (process 0407 ) and run the cycle again. If there is no confirmation from the telephone, the diagnostic unit (0210) instructs the communications unit 35 (0211) to check the connection again (process 0405). If at any time the memory unit (0209) has a malfunction, the diagnostic unit (0210) rechecks the operation of the memory unit (0209) (process 0402). In the event of an error, the diagnostic unit (0210) informs the management unit (0204) that it is not operational (process 0401) and checks again 40 the memory unit operability (0209) (process 0402). If the memory unit (0209) works correctly, the diagnostic unit (0210) informs the management unit (0204) that it is operational again (process 0406).

FIG. 5a-d show the exact position of each electrode, which are described below: The electrode (0501) (precordial electrode C1) is located in the fourth right intercostal space on the right edge of the sternum. Electrode (0502) (precordial electrode C2) is located in the fourth left intercostal space on the left edge of the sternum. Electrode (0503) (precordial electrode C3) is between (0502) and (0504). The electrode (0504) (precordial electrode C4) is located in the middle clavicular line at the height of the left nipple. The electrode (0505) (precordial electrode C5) is located in the

anterior axillary line. Electrode (0506) (precordial electrode C6) is located in the mid axillary line. The electrode (0507) (right arm electrode RA) is located in the intercostal space immediately above the electrode (0501).

The electrode (0508) (left arm electrode LA) is located in the intercostal space 5 immediately above the electrode (0502). The electrode (0509) (left leg electrode LL) is located vertically four intercostal spaces below the electrode (0505). The electrode (0510) (right leg electrode or neutral electrode AL) is positioned vertically just below the electrode (0509). The temperature unit (0205) is characterized in that it contains a thermistor that measures and records the body temperature of the patient (0101). It has a contact terminal (0511) placed in the middle axillary area just above the precordial electrode C6 (0506) (FIG 5a-d). The blood pressure unit (0207) consists of a reflectance photoplethysmograph, which measures the patient's blood oxygen saturation (0101) and calculates his blood pressure.

 fifteen

To do this, it has a photodiode, a red light emitting LED and another infrared light emitting LED encapsulated in the head (0512) located in the intercostal space immediately above the precordial electrode C3 (0503) (FIG. 5a and FIG. 5c) or vertically just above the LL electrode (0509). The multifunctional patch (0102) is manufactured in different sizes (Fig. 24 and 25) to adapt the position of the 20 electrodes of the electrocardiography unit (0202) and the contact terminals of the temperature (0205) and voltage unit arterial (0207) to the size of each person.

In addition, it has a specific design for use in male patients (FIG. 5a and 5b) and another with a better adaptability to the woman's breast (FIG. 5c and 5d). In the 25 women patch a remarkable ergonomic difference is shown with respect to that of the men, because it presents a circumference that shapes the lower part of the female breast (Fig. 24). This allows greater adaptability, support and comfort for use, without mobility or lack of contact of the electrodes with the patient's skin (0101). 30

Fig. 6a-b, of the multifunctional patch (0102) shows its multilayer manufacturing that gives flexibility and adaptability to the patient's movements without losing support or skin contact. The intermediate layer (0602) consists of a flexible printed circuit board, which acts as a physical support for the patch (0102), where all electronic circuits are implemented. In turn, this layer is protected by a cover composed of the sheets (0601 and 0603), made of resistant, flexible and waterproof material that prevents damage to the electronics, shock or liquid filtration.

In addition, this coating gives the patch the ergonomic shape (0102), exposing the electrodes and contact terminals that detect the physiological signals.

The layer (0604) consists of a hypoallergenic and breathable two-sided adhesive film that keeps the patch (0102) adhered to the patient's skin (0101) for 30 days, and can be replaced by another when necessary. Four. Five

The self-diagnostic algorithm

It is characterized by detecting alterations in the patient's vital signs (0101) automatically and identifying the associated cardiovascular pathologies. This algorithm, 50 based on complex signal processing techniques, analyzes the geometry of the

waveform that presents the cardiac electrical impulse in the twelve leads of the electrocardiogram and determines the characteristic points of each signal. From these points, the algorithm determines if the pulse is normal or presents anomalies of amplitude, periodicity or any other characteristic that allows to identify an underlying cardiovascular pathology. In addition, in case of detecting any cardiac alteration 5, the algorithm complements its diagnosis with the analysis of the rest of the other vital signs, also recorded by the patch (0102), such as the values of blood pressure, temperature, inclination of the patient's body , blood oxygen saturation, heart rate, respiratory rate and any other variable recorded through the peripheral sensor unit (0201). 10

FIG. 7 shows a flow chart showing the general processes in which the execution of the self-diagnosis algorithm is divided. When the doctor first puts the patch (0102) on the patient (0101), he makes a record of the complete electrocardiogram and all its vital signs. These values are used as a reference to carry out the diagnosis and correctly assess the patient's health status (0101). Once the reference values have been stored in the memory (0209) of the patch (0102), the algorithm continuously evaluates the patient's condition (0101) by analyzing only the DII derivation (process 0701). If there is an anomaly associated with a cardiovascular pathology, the algorithm records in alarm 20 (0209) of the patch (0102) an alarm notification (process 0706), which will be transmitted to the telephone by the communications unit (0211).

In addition, the algorithm immediately analyzes the rest of vital signs to complete the diagnosis (process 0707). In the case of detecting anomalies in these other 25 constants, the algorithm attached to the previous alarm notification additional information that contributes to assess the patient's condition more accurately (process 0708). The systematic, when analyzing the twelve leads of the electrocardiogram, is to determine different parameters and compare them with their

reference values (0702 and 0704). The parameters calculated from every 30 derivation are:

Heart rate: (Fig. 15) When recording the heart's electrical pulse, the DII shunt will be measured initially, measuring the time between each R wave to determine the heart rate; what on paper entails having to count the 35 frames between a QRS complex and the next one; This function is developed by our software automatically, indicating at all times the patient's HR and its variations: HR> 100 ppm (Sinus Tachycardia) or HR <60 ppm (Sinus Bradycardia). Interpretation time saved: 10-30 seconds; In addition to the advantage of continuous monitoring. 40

Rhythm: (Fig. 16) Arrhythmias are very common pathologies in the population. Many times they are subclinical, going unnoticed both for the patient and for the medical staff. Due to this and because it constitutes the basis of numerous pathologies, it is convenient to have them controlled. Making an ECG is the most accurate way to detect an arrhythmia, since it is the only technique that allows you to explore the electrical phenomena that occur in the heart. Within the ECG interpretation system, the first step is to see if there is sinus rhythm. The sinus module emits regular impulses that stimulate atrial contraction, this electrical impulse known as depolarization extends as a wave that is recorded in the ECG as a P wave. If in the ECG all complexes are preceded by

a P wave, we will say that the patient is in sinus rhythm. If this does not happen, we could face an extrasystole.

Wave P: It is the first wave of the electrocardiogram, this represents depolarization, and contraction of the atria of the heart, the wave is positive in all leads, 5 except in VR and sometimes, it is flattened or negative in D3. In the precordial lead V1 you can be biphasic, in these cases the electronegative end position corresponds to the left atrium. Its morphological aspect is useful as an indication of disease in entities that affect hemodynamics on the atria, especially in stenosis, mitral regurgitation, and in hypertensive pulmonary heart disease. 10

QRS complex: (Fig. 17) after each P wave must follow a wave complex called QRS complex, not all leads have the characteristic complex of three waves, the first being the Q wave (negative), the second wave R (positive) and the third wave S (negative). The DII derivation has the characteristic complex and is one more reason why the reference derivation is considered to detect alterations quickly, since the DII derivation roughly represents the rest of the cardiac derivations.

Electric Axis: (Fig. 18) The direction of the electrical stimulus along the heart is represented by a vector, said vector indicates the direction followed by most electrical impulses. The vector varies, as the electrical stimulus travels through the cardiac conduction system and it is possible to calculate it using any two leads. Knowing the electrical axis allows us to locate a certain conduction alteration, in this way we can know if a myocardial infarction is anterior or posterior and in this way intuit in which coronary artery the obstruction has occurred. Likewise, changes in the axis of the heart tell us if the heart has modified its shape by presenting growth of any of its parts that can affect the hemodynamics of the patient.

 30

Hypertrophy: (Fig. 19) An increase in wall thickness of any of the chambers of the heart can significantly alter the ECG, so it is convenient to take this information into account to avoid the unnecessary activation of alarms. In most cases, cardiac hypertrophy goes completely unnoticed clinically and the patient can lead a normal life; but it is advisable to take them into account so that they do not interfere with the algorithm. This will be avoided by having as reference the initial electrocardiogram of the patient, where it will be possible to assess whether hypertrophy already exists and where the heart axis is located.

Blocking: (Fig. 20) The heart is formed by four cavities: two upper cavities 40 (atria) and two lower cavities (ventricles). The sinoatrial node (SA), located near the top of the right atrium, emits electrical signals that are sent to the atrial ventricular node (AV). The AV node sends the signals to the ventricles, which are the main pumping cavities of the heart. When the heart works well, the electrical signals are transmitted smoothly from the atria to the ventricles, resulting in rhythmic muscle contractions that pump blood to the rest of the body. There are three types of cardiac obstruction, which vary from mild to severe:

a) First degree heart block: it is the mildest form of heart block. In this case, the electrical signals of the SA node move slower than normal towards the AV node, but all the signals reach the ventricles.

b) Second degree cardiac block: a second degree cardiac obstruction 5 means that some of the electrical signals are not reaching the ventricles. This causes "sagging beats." and these are subdivided into:

Type 1 second degree heart block (also called Mobitz Type 1 or Wenckebach AV obstruction) 10

Type II second degree heart block (also called Mobitz Type II).

c) Third degree cardiac block (or complete cardiac obstruction): it is the most serious type of cardiac obstruction since no electrical signal from the SA node is reaching the ventricle, this causes the heart to not produce rhythmic contractions and can lead to patient death

ST segment: (FIG. 21) The ST segment together with the T wave represents the forces originated in the process of repolarization and ventricular relaxation that corresponds to the filling of blood from the ventricles. The ST segment would correspond to the interval between depolarization and repolarization. This segment is measured from point J to the beginning of the T wave. It has a length of up to 0.15 s, a magnitude that lacks clinical importance, since the essential thing in this sector of the electrocardiogram is the presence of its leads or displacements of the isoelectric line 25. These displacements can originate in pathological situations or as an expression of the influence of purely physiological factors. The physiological displacements have a limit that has been considered of 1mm in standard leads and up to 2mm in the precordial leads. The displacements of the ST segment are the form of expression of the injured myocardial tissue, constitute an essential factor in the different phenomena that occur in myocardial infarction and indicate the acute phase of its evolution. In our algorithm we look at the displacements of the ST segment, based on their morphological aspects, and especially in the positive or negative sense that their disturbances show.

 35

T wave: (Fig. 22) The T wave, next to the ST segment, is part of the ventricular repolarization process. The T wave is usually more prominent in the precordial leads. The positive or negative orientation of T is important, as well as the correlation of this variable with other sectors of the electrocardiogram, especially with the ventricular complex and the ST segment. The T wave is always negative in VR, occasionally negative in V1 and V3, and exceptionally negative in VL, on the other hand the T wave is always positive in D1 and D2, VF, V2 through V6 and usually VL.

Infarction: (Fig. 23) One of the most frequent and most easily identifiable cardiac pathologies on the ECG is myocardial infarction. Diagnosing it is one of the main objectives of our system, since detecting them in time, or even before it occurs, greatly influences their morbidity and mortality. An AMI goes through three well-defined phases, all of them have representation in the electrocardiographic tracing. A first phase of ischemia, where due to an obstruction in a coronary artery, the oxygen supply to the underlying tissue is interrupted. In the ECG the ischemia is 50

I would see it as an inversion of the T wave, this would be followed by a tissue injury that would be represented in most cases by an ST segment elevation.

Finally, the appearance of Q waves on the ECG would complete the suspicion of a heart attack.

 5

We must bear in mind that it is important to know whether or not the ST segment elevation occurs, since the mode of action in each case is different. Before a variation of any parameter indicating in the algorithm, an alarm will be activated automatically, which will arrive at the Medical Control Center, where a specialized team decides how to intervene in each case and if it is necessary to activate the corresponding emergency protocol 10. To complement the electrocardiogram analysis, the algorithm compares the other vital signs recorded by the patch (0102) with their corresponding reference values. The complementary constants are:

Blood Pressure: Usually, blood pressure readings are given in two numbers, for example 120 over 80 (written as 120/80); The first number is called the systolic blood pressure (PS) reading and represents the maximum pressure exerted, when the heart contracts and the blood is ejected into the bloodstream. The second number (the lowest) is called a diastolic blood pressure (PD) reading and represents the pressure in the arteries, when the heart is at rest while it is filled with blood. Arterial Tension is defined as the pressure exerted by the circulating volume of blood on the walls of arteries, veins and cardiac chambers. The global blood pressure is maintained by the complex interaction of organic homeostatic mechanisms, moderated by the volume of the blood, the lumen of the arteries and arterioles and the force of cardiac contraction. Blood pressure is modified in response to cardiac alterations and provides much information about the hemodynamic state of the patient. In the same way, blood pressure may be altered even though the patient has a normal electrical rhythm. Likewise, if the patch detects an alteration in the heart rate, it will measure the blood pressure to complement the diagnosis. 30

Blood Oxygen Saturation: Oxygen saturation is the amount of oxygen that is combined in the chemical sense, with hemoglobin to form oxyhemoglobin, which is the element that carries oxygen in the blood to the tissues. Optimal saturation levels ensure that the body's cells receive the right amount of oxygen. Oxygen is a vital element for many cellular processes. The adequate percentage of oxygen in the blood is considered to be between 96 and 99 percent. Below 90 percent saturation, hypoxemia occurs, that is, an abnormal decrease in the partial pressure of oxygen in arterial blood, with which the tissues no longer receive the oxygen necessary to perform their functions. An oximetry can be performed to assess the adequacy of oxygen levels (or oxygen saturation) in the blood in a variety of circumstances such as surgery, other procedures that involve sedation (for example, bronchoscopy), adjustment of Complementary oxygen as needed, the efficacy of the lung medications, and if the patient exhibits tolerance to higher levels of activity. Another 45 reasons that can influence are the following, not limited to:

1.- Mechanical ventilation: the use of a ventilator to maintain sleep apnea breathing, periods of interruption of breathing during sleep.

 fifty

2.- Diseases such as heart attack, congestive heart failure, chronic obstructive pulmonary disease (COPD), anemia, lung cancer, asthma or pneumonia. When patients have cardiovascular disorders, oxygen saturation is diminished.

 5

Respiratory rhythm: Our device monitors for 24 hours the cycle of regular oscillation of inspiration and expiration, controlled by neuronal impulses transmitted between the inspiratory muscles of the thorax and the respiratory center located in the brain. In the case of a cardiovascular disease, the respiratory rate is one of the first parameters, which are modified to try to compensate for the cardiac alteration, which affects the distribution of oxygenated blood throughout the body. In such a way that when detecting a cardiac alteration, it will be assessed if the respiratory rate has changed.

Body temperature: With the constant monitoring of our device, it is intended to have any variation in the normal body temperature controlled, which varies according to the person, age, activity and time of day. The average normal body temperature that is generally accepted is below 37 ° C. Some studies suggest that there is a wider range of "normal" body temperatures. Before a temperature above 37.2 - 37.5 ° C our device would generate an alarm, indicating to the patient and to our Medical Control Center, that the patient has a temperature rise so that it is controlled; which can be caused by an infection, a disease, or when the patient has rhythm alterations especially in tachycardia, since for example the fever alone increases the heart rate and respiratory rate, many patients with fever 25 have sinus tachycardia

Degree of inclination of the patient's body: This unit contains a three-dimensional accelerometer, and a verticality sensor. When you notice an abrupt change in acceleration, combined with a change in verticality, it sends an alarm to the device, 30 to notify the possible fall of the patient. This allows our device, to have 24 hours a day controlled for all those users, who due to their cardiovascular disease can present a loss of consciousness, or because they have a high risk of falls due to their mobility, or age; lead a completely normal life and minimizing as far as possible the results of the fall, since the help mechanisms are activated automatically and immediately by sending a fall alarm signal to the mobile phone, and this to the Control Center Doctor, to proceed to activate the emergency medical action protocol. In this way we can prevent a person who has suffered a fall, due to heart failure, heart attack, and / or dizziness due to the alteration of one of the vital signs 40, in any place where they are and remain without receiving immediate medical attention

Smart mobile phone

 Four. Five

The mobile smart phone (0103) acts as a communication bridge between the patch (0102), the remote medical control center (0104) and the patient (0101). This phone is characterized in that it contains a software application, which is responsible for managing the way in which the phone (0103) interacts with the patient (0101), with the patch (0102) and with the medical control center (0104). fifty

FIG. 8 shows the different modules that comprise the design of this software application. The GPS module (0801) uses the electronic GPS device integrated in the phone (0103) to periodically calculate the GPS position of the phone and record the coordinates in the memory module (0803). The communications module (0802) uses the Bluetooth receiver, integrated in the telephone (0103) to receive the data that the patch sends (0102). As the information is received, it is stored directly in the memory module (0803). The memory module (0803) stores all the information as it is received from the patch (0102). The information that is stored contains the values of the patient's vital signs (0101), the alarms that the patch could identify (0102) as well as the coordinates recorded by the GPS module (0801). The alarm module (0804) is responsible for evaluating any incident or technical failure that occurs in the operation of the telephone (0103) and for recording it in the memory module (0803). The external communications module (0805) sends the data registered in the memory module (0803) to the remote Medical Control Center (0104) via the Internet, using Web services hosted on the server 15 of the Medical Control Center (0104) . The graphical interface module (0806) monitors, through the telephone screen (0103), all the information of the patient's vital signs (0101) that is registered in the memory module (0803), and makes a description of alarms or technical failures registered by the alarm module (0804), as well as those transmitted by the patch (0102) to the mobile phone (0103). twenty

FIG. 9 shows a flow chart representing the general operating dynamics of the software application installed in the mobile phone (0103). Initially, the communications module (0802) waits for a connection request from patch (0102) (process 0901). If the waiting time is fulfilled and such a request is not received in the external communications module (0805), it transmits a technical alarm to the medical control center (0104) (process 0916) and the graphic interface module (0806 ) shows on the screen (FIG. 10m) of the mobile phone (0103) an indicator that informs the patient (0101) that the phone (0103) is not communicating with the patch (0102) (process 0910). If the request is received, the communications module (0802) 30 attempts to establish the connection with the patch (0102) (process 0902). If there is no connection, the external communications module (0805) transmits a technical alarm to the Medical Control Center (0104) (process 0916) and the graphic interface module (0806) informs the patient (0101) through the screen (FIG. 10m) of the telephone (0103) (process 0910). If the connection is established normally, the application expects data to be sent by patch (0102) (process 0903). If the timeout expires and the data has not been received, the external communications module (0805) sends to the Medical Control Center (0104) an alarm informing that the telephone (0103) and the patch (0102) are incommunicated (process 0916). In addition, the graphic interface module (0806) notifies the patient (0101) through the screen (FIG. 10m) of the mobile phone 40 (0103) that the two devices are not communicated (process 0910). In case of receiving the data correctly, the communications module (0802) sends to the patch (0102) a notification to confirm that the reception of the information has been carried out successfully (process 0904). Once the data is received, the GPS module (0801) obtains the location of the telephone (0103) (process 0905). Next, both the data sent by the patch (0102) and the GPS coordinates are stored in the memory module (0803) (process 0906). Next, the external communications module (0805) sends the information stored in the memory module (0803) to the Medical Control Center (0104) (process 0907) and the graphic interface module (0806) represents the patient's vital signs ( 0101) through the screens (FIG. 10c-l) of the mobile phone (0103) (process 0908). Subsequently, the alarm module (0804)

evaluates whether there are alerts registered in the memory module (0803) (process 0909). If there is an alarm and it is of a medical type, the graphic interface unit (0806) notifies the patient of the situation through the screen (FIG. 10m) of the telephone (0103) (process 0910). At this point, the application restricts incoming calls (process 0911) and waits for the call from the Medical Control Center (0104) (process 0912). If call 5 is answered by the patient (0101), the application simply waits until the conversation ends (process 0915). If the patient (0101) does not answer the call within 10 seconds, the application answers the call automatically (process 0913) and activates the "hands-free" option (process 0914). In this way, the patient (0101) can talk to the Medical Control Center (0104) even when he cannot answer the telephone (0103). In the event that the alarm module (0804) detects the registration of a technical alarm in the memory module (0803) or identifies any incident in the operation of the software application, the graphic interface module (0806) shows by the screen (FIG. 10m) of the mobile phone (0103) a description of the fault to inform the patient (0101). If there is no alarm or if there has been any attention, whether medical or technical, the application waits again for the reception of new data by the patch (0102).

Fig. 10 describes the different screens that it executes together with the module of the mobile phone's graphic interface. twenty

Fig. 10a: Main screen of the smart mobile phone showing the icon that gives access to the software application.

Fig. 10b: This screen shows the access control to the medical system, indicating the place where the data should be placed:

a) .- The Iogo of the Application at the top b) .- The name of the cardiovascular doctor of the patient affiliated with the system, the doctor of the Medical Control Center, the external doctor with provisional authorization, and / or the technician of the Center of Medical Control c) .- The 30 user code authorized to enter the system, and assigned by the Medical Control Center. d) .- The start of the program once the identification entered by the user has been accepted.

Fig. 10c: The screen shows the patient data and the contents on different screens 35 for accessing the medical system program:

Main screen: a) .- The patient's registration number, b) .- The patient's name and surname, c) .- The patient's Medical History number.

 40

Screen. 1.- a) .- Sub-screens describing cardiovascular leads: 1.- Bipolar leads DI, DII, DIII. 2.- Monopolar derivations, aVL, aVR, aVF, 3.- Precordial derivations V1, V2, V3. 4.- Precordial derivations V4, V5, V6. 5.- Summary of Bipolar derivations. 6.- Summary of Precordial derivations. Four. Five

Screen. 2.- b) .- Sub-screens describing the vital signs No. 1, 1.- Blood Pressure in Mg., 2.- Heart Rate in bpm. 3.- Oximetry (Blood oxygen saturation)% saturation.

 fifty

Screen. 3.- c) .- Sub-Screens describing vital signs No. 2. 1.- Respiratory Rate. 2.- Body temperature in ºC. 3.- Summary of vital signs.

Fig. 10d: Shows the patient data that are linked together with a graphic screen with the Bipolar leads DI, DII, DIII, of the electrocardiogram. 1.- The 5 date and time of the request for the data. 2.- The patient's registration number. 3.- The name and surname of the patient. 4.- The number of the patient's medical history. 5.-The denomination of the graph that is observed on the screen. 6.-Graph with leads DI, DII, DIII.

 10

Fig. 10e: Shows the patient data that are linked together with a graphic screen with the limbs, aVR, aVL, aVF, of the electrocardiogram: 1.- The date and time of the request for the data. 2.- The patient's registration number. 3.- The name and surname of the patient. 4.- The number of the patient's medical history. 5.- The denomination of the graph that is observed in the 15 screen. 6.- Graph with the derivations aVR, aVL, aVF.

Fig. 10f: Shows the patient data that are linked together with a graphic screen with the Precordial leads, V1, V2, V3, of the electrocardiogram:

 twenty

1.- The date and time of the data request. 2.- The patient's registration number. 3.- The name and surname of the patient. 4.- EI is seen on the screen. 6.- Graph with leads V1, V2, V3.

Fig. 10g: number of the patient's medical history. 5.- The name of the graph that 25 Shows the patient data, which are related together with a graphic screen, with the Precordial leads, V4, V5, V6, of the electrocardiogram: 1.- The date and time of the request for the data. 2.- The patient's registration number. 3.- The name and surname of the patient. 4.- The number of the patient's medical history. 5.- The denomination of the graph that is observed on the screen. 6.- Graph with the 30 leads V4, V5, V6.

Fig. 10h: This screen describes the patient data and as a summary of cardiovascular activity, the Bipolar leads of the following electrocardiogram: 1.- The date and time of the request for the data. 2.- The patient's registration number. 35 3.- The name and surname of the patient. 4.- The number of the patient's medical history. 5.- Graph with leads DI, DII, DIII, aVR, aVL, aVF.

Fig. 10i: This screen describes the patient's data and as a summary of cardiovascular activity, the Precordial leads of the electrocardiogram: 1.- The date and time of the request for the data. 2.- The patient's registration number. 3.- The name and surname of the patient. 4.- The number of the patient's medical history. 5.- Graph with leads V1, V2, V3, V4, V5, V6.

Fig. 10j: This screen shows three of the vital signs, indicating the data 45 on the screen. one.-

1.- Blood pressure: a) .- Value of systolic blood pressure, b) .- Value of diastolic blood pressure, e) .- Value of mean blood pressure (MAP).

 fifty

2.- Heart Rate Frequency: a) .- Heart Rate Frequency Value,

3.- Oximeter: a) .- Spo2 value in blood.

Fig. 10k: This screen shows, (2) the patient registration number and the two vital signs, indicating the data on the screen. fifteen

1.- Respiratory rhythm: a) .- Respiration value per minute.

2.- Body temperature: a) .- Temperature value, b) Graph with temperature record in the last hours, night or day, c) light warning of high or low temperature.

Fig. 10l: This screen shows the patient data and a summary of the vital signs data as they have been developed: a) Patient number, b) Patient name, c) Patient history number, d ) Date of the request, 15 e) Date on which the event occurs, f) Time at which the event occurs, g) Blood pressure data, (systole, diastole, PAM), h) Heart rate , i) body temperature, j) Oxygen saturation.

Fig. 10m: This screen shows the patient data, and the alarms that can be produced, and that will be illuminated with an icon corresponding to said alarm with a message indicating what happens and what should be done: a) Patient number, b) patient name, c) Date on which the alarm occurs, d) an alarm identification, e) Icon related to an alarm of problems in the patch, and to the right of the icon a text message , f) Icon related to the inadequacy of the battery supply 25, and to its right a text message of what to do, g) Mobile phone icon, which may have a text message to the right of the phone icon , indicating the incidence, or you can issue a voice message giving the patient indications of what to do in case of not answering the call to the doctor, from the control center when an event occurs, h) Blood pressure icon, with a 30 text message to the right of the icon what to do, i) Body temperature icon, with a text to the right of the icon that indicates the feverish state of the patient and what to do.

Medical control center

 35

The medical control center (0104) is responsible for managing the patient information (0101) that it receives from the mobile phone (0103), and for ensuring the correct functioning of the system, as well as for executing all the actions involved in the activation of the Health care protocol, in case of an emergency situation.

 40

Fig. 11 shows the different parts that make up the functional structure of the medical control center (0104). The medical control center (0104) is characterized in that it contains a battery of servers (1102). These servers include a web application that receives patient information (0101) sent from the mobile phone (0103) via the Internet and a database where all the information received is stored. Likewise, the medical control center (0104) is characterized in that it contains a team of operators (1101). These operators have nursing knowledge and are responsible for managing and coordinating the protocol of action of the medical control center (0104). On the other hand, the medical control center (0104) also has the medical team (1103), which specializes in cardiovascular emergency care 50, and the technical team (1104), trained to solve any

technological impact that affects the proper functioning of the system. Finally, the medical control center (0104) is characterized in that it contains a management software that controls access to the database installed on the servers (1102), manages patient monitoring (0101), notifies any alarm to operators (1101) and coordinates the operation of the entire center in general. 5

FIG. 12 shows a flow chart detailing the operating dynamics of this software. Initially, the management software verifies the access code of the user who intends to access the information stored on the servers (1102) (process 1201). In the case of personnel belonging to the medical control center 10 (0104), the management software accesses the database (1102) and shows the patient information (0101), in real time, through the monitors ( 1101) (process 1202). At the same time, the software evaluates whether an alert has been received from the mobile phone (0103) (process 1213). If so, it determines whether it is a medical or technical type alert (process 1204), showing by monitors (1101) a detailed description of the alarm received. If it is a medical type alarm, the software shows by the monitors (1101) the location of the patient (0101) (process 1205), the address of the nearest hospital (process 1206) and the access code to the servers of the Medical control center (0104) (process 1207). On the other hand, if the user who intends to access the database (1101) is external staff with a temporary access code given by the medical control center (0104), the management software shows the patient the patient's history (0101) (process 1208) as well as its evolution through the monitoring of its vital signs in real time (process 1209). For this, the user in question must indicate the patient's history number (0101). These access codes for external personnel are temporary or permanent, depending on the affiliation or not, of the system's health care service program.

Operating dynamics of the medical control center

 30

In the event that the multifunctional patch (0102) detects an underlying cardiovascular pathology in the patient (0101), the medical control center (0104) sets up a medical care protocol optimized to assist the affected person in situ and in a minimum time

 35

FIG. 13 shows a graphic representation of the general operating dynamics of the medical control center (0104).

Emergency medical action protocol

 40

Fig. 14 shows a flow chart of the action protocol in case of an emergency situation. On an uninterrupted basis, the operators (1101) of the medical control center (0104) constantly monitor the general operation of the system and attend to any alarm that has been registered in the database (1102) (process 1401). If the management software notifies a technical alarm to operators 45 (1101), the technical team (1104) immediately communicates with the patient (0101) to verify and correct the problem. If this is not achieved, the technical staff (1104) moves to the patient's home (0101) along with medical team personnel (1103) to solve the problem. If the management software notifies a medical alarm, the operator (1101) immediately communicates it to the medical department (1103). 50 This proceeds to evaluate the parameters of the patient (0101) to determine if it is

a medical emergency or not (process 1402). If a possible state of urgency is confirmed, the medical department (1103) will proceed to call the patient (0101) to his mobile phone (0103) to make a brief interrogation in order to know what his state of health is, confirm the symptomatology and determine if you are facing a cardiovascular event in process (process 1403). 5

If so, the doctor (1103) declares the state of emergency and authorizes the operator (1103) to implement the medical assistance protocol (process 1404).

At this point, while the doctor (1103) talks to the patient (0101), the 10 operator (1101) notifies the medicalized ambulance (1301) informing him of the exact location of the patient (0101) and the address of the hospital (1302) closest (process 1405). At the same time, the doctor (1103) communicates with the emergency service of the clinic and / or hospital (1102) where the patient is going to be transferred (0101), indicating the arrival of the patient as well as his state of health so that Prepare to attend to it (process 1408). On the other hand, the receiving hospital (1302) receives the temporary access code (1409) that allows it to access, in real time, the patient information (0101) stored in the database (1102) of the control center doctor (0104).

Finally, the doctor (1103) notifies the patient's situation (0101) to his cardiovascular physician 20 (process 1410) and family members (process 1411).

Description of the figures

FIG. 1: General scheme of the system. This figure shows the different parts 25 that make up the system we present, as well as the way they interact with each other.

FIG. 2: Electronic implementation of the multifunctional patch. This figure shows a representative diagram of the electronic architecture with which the multifunctional patch 30 is designed. It shows the different units that compose it as well as the way in which they interact with each other.

FIG. 3: Flow diagram representing the sequence of processes involved in the operation of the management unit implemented in the electronic architecture of the multifunctional patch.

FIG. 4: Flow chart representing the sequence of processes involved in the operation of the diagnostic unit implemented in the electronic architecture of the multifunctional patch 40

FIG. 5th: Plan of the multifunctional patch for men has a contact terminal, with a blood pressure measurement head, located in the intercostal space immediately above the precordial electrode C3. This figure shows the electrocardiograph electrode distribution as well as the contact terminal for taking the blood pressure.

FIG. 5b: Multifunctional patch plan for men has a contact terminal, with a blood pressure measurement head located vertically just above the LL electrode. This figure shows the electrocardiograph electrode distribution; 50 as well as the contact terminal for the thermometer.

FIG. 5c: Multifunctional patch plan for women, it has a contact terminal, with a blood pressure measurement head, located in the intercostal space immediately above the precordial electrode C3. This figure shows the electrocardiograph electrode distribution; as well as the contact terminal for taking blood pressure. 5

FIG. 5d: Multifunctional patch plan for women has a contact terminal, with a blood pressure measuring head located in the intercostal space immediately above the precordial electrode LL. This figure shows the electrocardiograph electrode distribution as well as the contact terminal for the thermometer.

FIG. 6a: Multilayer structure of the multifunctional patch with the blood pressure head, located in the intercostal space immediately above the precordial electrode C3. This figure shows a three-dimensional representation of the structure with which the patch is made. In it you can see the different layers that compose it.

FIG. 6b: Multilayer structure of the multifunction patch with the blood pressure head, located vertically just above the LL electrode. This figure shows a representation in three dimensions on the structure with which the patch is made. In it you can see the different layers that compose it.

FIG. 7: Flowchart, which represents the sequence of processes involved in the self-diagnosis algorithm installed in the patch. 25

FIG. 8: Design architecture of the software application, installed on the mobile smart phone. This figure shows a representative diagram of the architecture with which the application installed on the phone is designed. It shows the different modules that compose it as well as the way in which they interact with each other. 30

FIG. 9: Flowchart, which represents the sequence of processes involved in the execution of the software application installed on the mobile smart phone.

FIG. 10a-m: Describes the different screens that it executes and displays together with the module of the graphic interface of the mobile phone software application.

FIG. 11: Graphical representation, in which the functional structure of the medical control center can be observed. And the different teams or departments that compose it as well as the way in which they interact with each other. 40

FIG. 12: Flowchart, which represents the sequence of processes involved in the operation of the management software, which uses the medical control center to control access to the database, manage patient monitoring, notify alarms and coordinates the operation of the entire center in general. Four. Five

FIG. 13: Graphical representation, which shows the different parts of the system that intervene in case of a medical emergency situation, as well as the way in which they interact with each other to attend to the patient as soon as possible and as effectively as possible.

 fifty

FIG. 14: Flowchart, which represents the sequence of processes involved in the dynamics of the emergency action protocol of the medical control center. In it you can see the way in which the medical control center acts in case of a medical emergency.

 5

FIG. 15: Graphical representation, showing the heart rate of the electrical impulses of the heart

FIG. 16: Graphic Representation, where the different arrhythmias are shown.

 10

FIG. 17: Graphical representation, where the QRS complex is shown.

FIG. 18: Graphical representation, where the complex shows the Electric Axis of the heart.

 fifteen

FIG. 19: Graphical representation, showing ventricular hypertrophy.

FIG. 20: Graphical representation, showing the different blocks of grade 1, 2, and 3.

 twenty

FIG. 21: Graphical representation, where the ST segment is shown.

FIG. 22: Graphical representation, where the T wave is shown.

FIG. 23: Graphical representation, where an infarction is shown on the electrocardiographic plot of a heart attack.

FIG. 24: Graphical representation of the different sizes of the female patch.

FIG. 25: Graphical representation of the different sizes of the male patch. 30

Claims (36)

1. Remote monitoring system for vital signs and automatic diagnosis of cardiovascular diseases that includes: a) a multifunctional patch (0102), which adheres to the patient's chest (0101) and is characterized by including integrated electronic circuits that register multiple vital signs simultaneously and 24 hours a day, for automatically identifying symptoms associated with cardiovascular pathologies, and for transmitting data in real time and wirelessly to a mobile terminal (0103); and b) (the) mobile terminal (0103), which is programmed with a data management and processing software application characterized by managing the reception and temporary storage of the data recorded by the multifunctional patch (0102), for displaying the constants vital on the mobile terminal screen (0103), for classifying the patient's health status (0101) in different emergency levels and for managing the transmission of data, in real time, to a remote medical control center (0104) via Internet. fifteen 2. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 1, characterized in that the multifunctional patch (0102) adheres to the human body.  twenty 3. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 1, characterized in that the morphology of the multifunctional patch (0102) is ergonomically adapted to the anatomy of the human body.  25 4. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 3, characterized in that the morphology of the multifunctional patch (0102) is adaptive to the anatomy of men of different sizes.  30 5. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 3, characterized in that the morphology of the multifunctional patch (0102) is adaptive to the anatomy of women of different sizes by means of an arc-shaped design in the part lower chest.  35 6. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 1, characterized in that the multifunctional patch (0102) contains ten surface electrodes that capture the electro-physiological signals of the patient (0101).   40 7. Remote monitoring system for vital signs and automatic diagnosis of cardiovascular diseases, according to claim 1, characterized in that the multifunctional patch (0102) contains a skin contact terminal for taking the patient's blood pressure (0101) .  Four. Five 8. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 1, characterized in that the multifunctional patch (0102), contains a skin contact terminal for taking oxygen saturation in the blood of the patient (0101).  fifty 9. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 1, characterized in that the multifunctional patch (0102), contains a skin contact terminal for taking the patient's body temperature (0101 ).  5 10. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 1, characterized in that the multifunctional patch (0102) is designed with a multilayer structure. 11. Remote monitoring system of vital signs and automatic diagnosis of 10 cardiovascular diseases, according to claim 10, characterized in that the multifunctional patch (0102) is designed with a multilayer structure containing the flexible printed circuit board (0602) that acts as physical support of the patch (0102) and where the electronic circuits are implemented.  fifteen 12. Remote monitoring system for vital signs and automatic diagnosis of cardiovascular diseases, according to claim 10, characterized in that the multifunctional patch (0102) is designed with a multilayer structure containing a coating layer (0601).  twenty 13. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 10, characterized in that the multifunctional patch (0102) is designed with a multilayer structure containing a coating layer (0603) exposing the electrodes and contact terminals that detect physiological signals. 25 14. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 10, characterized in that the multifunctional patch (0102) is designed with a multilayer structure containing an elastic layer (0604) coated on both sides with adhesive . 30 15. Remote monitoring system for vital signs and automatic diagnosis of cardiovascular diseases, according to claim 1, characterized in that the electronic implementation of the multifunctional patch (0102) includes a set of independent hardware units or modules. 35 16. Remote monitoring system for vital signs and automatic diagnosis of cardiovascular diseases, according to claim 15, characterized in that the multifunctional patch (0102) includes a hardware module (0201) that receives data from sensors outside the patch (0102) and that Contains a data transmitter / receiver of 40 Bluetooth technology. 17. Remote monitoring system for vital signs and automatic diagnosis of cardiovascular diseases, according to claim 15, characterized in that the multifunctional patch (0102) includes a hardware module (0202) that measures the electrical impulses 45 of the patient's heart (0101) and that contains an integrated electrocardiograph of twelve leads. 18. Remote monitoring system for vital signs and automatic diagnosis of cardiovascular diseases, according to claim 15, characterized in that the multifunctional patch (0102) includes a hardware module (0203) that supplies power electric patch (0102) and containing an electric battery and an electronic circuit for electric power management. 19. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 15, characterized in that the multifunctional patch (0102) includes a hardware module (0205) that measures the patient's body temperature (0101) and that It contains a thermistor. 20. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 15, characterized in that the multifunctional patch (0102) includes a hardware module (0206) that measures the inclination of the patient's body (0101) in the three spatial axes and containing a three-dimensional accelerometer. 21. Remote monitoring system of vital signs and automatic diagnosis of 15 cardiovascular diseases, according to claim 15, characterized in that the multifunctional patch (0102) includes a hardware module (0207) that measures blood oxygen saturation and blood pressure of the patient (0101) and containing a reflectance photoplethysmograph, a photodiode, a red light emitting LED and another infrared light emitting LED. twenty 22. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 15, characterized in that the multifunctional patch (0102) includes a hardware module (0208) that alerts the patient (0101) about any failure or incident occurred during the operation of patch 25 (0102) and containing luminous, acoustic and vibratory indicators. 23. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 15, characterized in that the multifunctional patch (0102) includes a hardware module (0209) that stores data and 30 that contains a dual-port electronic memory . 24. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 15, characterized in that the multifunctional patch (0102) includes a hardware module (0211) that establishes a wireless communication with the smart mobile phone (0103 ), and it contains a Bluetooth transmitter / receiver. 25. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claims 23 and 24, characterized in that the multifunctional patch (0102) includes a hardware module (0210) that detects alterations in the patient's vital signs ( 0101) associated with cardiovascular pathologies by processing the data stored by the unit (0209), and containing a microcontroller configured to perform the tasks detailed in the text: a) Declare the status of the unit (0210) inoperative, b) verification of the operation of the unit (0209), c) verification of the operation of the unit (0211), d) search of the mobile phone (0103) by means of the unit (0211), e) establish the connection with the mobile phone (0103) through unit (0211), f) declare the status of the unit (0210) operational, g) wait for data availability in the unit (0209), h) read data, i) p friction of the data stored by the unit (0209) and 50 detection of alterations in the patient's vital signs (0103), j) sending of the data stored in the unit (0209) and the result of the diagnosis to the unit (0211), k) wait for the unit confirmation (0211) that the mobile phone (0103) has received the data correctly. 26. Remote monitoring system of vital signs and automatic diagnosis of 5 cardiovascular diseases, according to claims 16, 17, 18, 19, 20, 21 and 25, characterized in that the multifunctional patch (0102) includes a hardware module (0204) which manages the overall operation of the patch (0102) and which contains a microcontroller configured to perform the tasks detailed below in the text: a) reading the status of the unit (0203), b) verifying the operation of the unit (0209), c) verification of unit operation (0202), d) verification of unit operation (0207), e) verification of unit operation (0205), f) unit verification of (0206), g) verification of unit operation (0201), h) search for peripheral sensors, i) establish connection with a peripheral sensor, j) reading of unit status (0203), k) check the operability of unit 15 (0210) , l) check tion of electrode operation, m) reading of data captured by the unit (0202) n) reading of data captured by the unit (0207), or) reading of data captured by the unit (0205), p) reading of data captured by the unit (0206), q) checking connection with peripheral sensor, r) reading data captured by the unit (0201), s) calculating vital signs, t) sending data to the unit (0209) for its storage. 27. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 15, characterized in that the multifunctional patch (0102) includes a hardware module (0212) containing a passive NFC technology label with the code of patch identification (0102). 28. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 1, characterized in that the mobile smart phone (0103) is programmed with a software application that is responsible for managing communication and data transfer between the multifunctional patch (0102) and the mobile terminal itself (0103), and at the same time, between the latter and a remote medical control center (0104). 29. Remote monitoring system of vital signs and automatic diagnosis of 35 cardiovascular diseases, according to claim 28, characterized in that the mobile smart phone (0103) is programmed with a software application that includes a module (0801) that manages the operation of a global positioning locator (GPS) integrated in the mobile smart phone (0103) and calculates the geo-location of the patient (0101). 40 30. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 28, characterized in that the mobile smart phone (0103) is programmed with a software application that includes a module (0802) that manages the operation of a Bluetooth transmitter / receiver 45 integrated in the mobile phone (0103). 31. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 28, characterized in that the mobile smart phone (0103) is programmed with a software application that includes a module (0803) that stores the information in an integrated internal memory on the mobile smart phone (0103), as patch data is received (0102). 32. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 28, characterized in that the mobile smart phone (0103) is programmed with a software application that includes a module (0806) that manages the visualization of data through a screen integrated in the mobile phone (0103). 33. Remote monitoring system of vital signs and automatic diagnosis of 10 cardiovascular diseases, according to claim 32, characterized in that the mobile smart phone (0103) is programmed with a software application that includes the module (0806) that manages the visualization of the data on the phone screen (0103) using a multi-screen graphic presentation.  fifteen 34. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claims 31 and 32, characterized in that the mobile smart phone (0103) is programmed with a software application that includes a module (0804) that evaluates any incident or technical failure that occurs in the operation of the mobile phone (0103) and sends a notification to the unit (0803) for storage and another unit (0806) to communicate it to the patient (0101). 35. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claim 28, characterized in that the mobile smart phone (0103) is programmed with a software application that includes a module (0805) that sends the stored data in the internal memory of the mobile phone (0103) to the remote medical control center (0104) via the Internet. 36. Remote monitoring system of vital signs and automatic diagnosis of cardiovascular diseases, according to claims 29, 30, 34 and 35, characterized in that the smart mobile phone (0103) is programmed with a software application whose operation involves the following processes of control: a) wait for the unit (0802) to receive a patch request from the patch (0102), b) establish communication with the patch (0102) through the unit (0802), 35 c) wait for reception of the data sent by the patch (0102), d) send to the patch (0102) a confirmation on the correct reception of the data, e) read the geo-location of the patient (0103) calculated by the unit (0801), f) storing the data received from the patch (0102) through the unit (0803), g) sending the data received from the patch (0102) to the medical control center (0104) via the unit (0805), h) 40 show the data received from the patch (0102) by the mobile phone screen (0103) through the unit (0806), i) evaluate the notifications about technical failures in the mobile phone (0103) generated by the unit (0804) , j) send notifications of technical failures on the mobile phone (0103) to the medical control center (0104) via the unit d (0805), h) show the patient (0101) the technical failure notifications on the mobile phone 45 (0103) via the unit (0806).